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| ID | Type | Description | Link |
|---|---|---|---|
| J1I-MC-GZBU | Other Identifier | Eli Lilly and Company | |
| 2023-504583-42-00 | Other Identifier | EU Trial Number |
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The main purpose of this study is to investigate the effect of retatrutide on renal function in participants with overweight or obesity and chronic kidney disease (CKD), with or without Type 2 Diabetes (T2D). The study will last around 31 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retatrutide | Experimental | Participants will receive multiple doses of retatrutide subcutaneously (SC) |
|
| Placebo | Placebo Comparator | Participants will receive LY3437943 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retatrutide | Drug | Administered SC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Glomerular Filtration Rate (mGFR) | The GFR in milliliter/minute per1.73 square meter (mL/min/1.73 m²) using iohexol clearance (mGFR-measured glomerular filtration rate) | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Urine Albumin-to-Creatinine Ratio (UACR) | Baseline, Week 24 | |
| Change from Baseline in Creatinine-Corrected Fractional Urinary Sodium Excretion (FENa) | Baseline, Week 24 | |
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Inclusion Criteria:
Have a body mass index (BMI) ≥27 kilogram/square meter (kg/m²)
Have either
Have been diagnosed with chronic kidney disease (CKD).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Institute for Liver Health II dba Arizona Clinical Trials - Mesa | Chandler | Arizona | 85225 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41160422 | Derived | Heerspink HJL, van Raalte DH, Bjornstad P, Bunck MC, Wu P, Tunali I, Milicevic Z, Koeneman L. Rationale, design and baseline characteristics of the TRANSCEND-CKD trial of retatrutide in patients with chronic kidney disease. Nephrol Dial Transplant. 2026 May 29;41(6):1058-1068. doi: 10.1093/ndt/gfaf230. |
| Label | URL |
|---|---|
| A Study of Retatrutide (LY3437943) on Renal Function in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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Phase 2b
| Placebo | Drug | Administered SC |
|
| Change from Baseline in Filtration Fraction Estimated from Measured Glomerular Filtration Rate (mGFR) |
| Baseline, Week 24 |
| Change from Baseline in Renal Mean Arterial Flow as Assessed by Magnetic Resonance Imaging (MRI), Corrected by Hematocrit | Baseline, Week 24 |
| Change from Baseline in in Mean Arterial Flow (MAF) | Baseline, Week 24 |
| Change from Baseline in Renal Artery Resistive Index (RARI) | Baseline, Week 24 |
| Change from Baseline in Renal Blood Flow Velocity Peak Systolic Velocity (PSV) and End-diastolic Velocity (ESV) | Baseline, Week 24 |
| Change from Baseline in Global Renal Perfusion (MRI) | Baseline, Week 24 |
| Change from Baseline in Total Renal Parenchyma Volume (MRI) | Baseline, Week 24 |
| Change from Baseline in Renal Cortex Volume (MRI) | Baseline, Week 24 |
| Change from Baseline in Renal Cortex T1 (ms) (MRI) | Baseline, Week 24 |
| Change from Baseline in Medulla T1 (ms) (MRI) | Baseline, Week 24 |
| Change from Baseline in Renal Cortex R2 (BOLD MRI) | Baseline, Week 24 |
| Change from Baseline in Medulla R2 | Baseline, Week 24 |
| Change from Baseline in Body Weight | Baseline, Week 24 |
| Change from Baseline in 24-hr Urinary Albumin Excretion (UAE) | Baseline, Week 24 |
| Change from Baseline in Change in 24-hour (hr) Urinary Electrolytes (milligrams/24hr (mg/24h)) | Baseline, Week 24 |
| Care Access - 801 South Power Road, Mesa |
| Mesa |
| Arizona |
| 85206 |
| United States |
| Headlands Research - Scottsdale | Scottsdale | Arizona | 85260 | United States |
| Medical Advancement Centers of Arizona | Tempe | Arizona | 85283 | United States |
| Hope Clinical Research, Inc. | Canoga Park | California | 91303 | United States |
| Catalina Research Institute, LLC | Montclair | California | 91763 | United States |
| Peninsula Research Associates | Rolling Hills Estates | California | 90274 | United States |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| Teradan Clinical Trials, LLC | Brandon | Florida | 33511 | United States |
| Suncoast Clinical Research, Inc. | New Port Richey | Florida | 34652 | United States |
| Great Lakes Clinical Trials - Ravenswood | Chicago | Illinois | 60640 | United States |
| Indiana University Health University Hospital | Indianapolis | Indiana | 46202 | United States |
| Prime Health and Wellness/SKYCRNG | Fayette | Mississippi | 39069 | United States |
| Palm Research Center Tenaya | Las Vegas | Nevada | 89128 | United States |
| NYU Langone Hospital - Long Island | Mineola | New York | 11501 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Victorium Clinical Research - Houston | Houston | Texas | 77024 | United States |
| Endocrine Ips, Pllc | Houston | Texas | 77079 | United States |
| Tranquility Research | Webster | Texas | 77598 | United States |
| Centricity Research Brampton Endocrinology | Brampton | Ontario | L6S 0C6 | Canada |
| Circulate Cardiac & Vascular Centre | Burlington | Ontario | L7M 1K9 | Canada |
| North York Diagnostic and Cardiac Centre | North York | Ontario | M6B 3H7 | Canada |
| Stouffville Medical Research Institute Inc. | Stouffville | Ontario | L4A 1H2 | Canada |
| Dr. Anil K. Gupta Medicine Professional Corporation | Toronto | Ontario | M9V 4B4 | Canada |
| Fadia El Boreky Medicine | Waterloo | Ontario | N2J 1C4 | Canada |
| Viacar Recherche Clinique | Greenfield Park | Quebec | J4V 2G8 | Canada |
| Diex Recherche Joliette | Joliette | Quebec | J6E 6A9 | Canada |
| 9109-0126 Quebec Inc. | Montreal | Quebec | H4N 2W2 | Canada |
| Centro Cardiologico Monzino | Milan | Milano | 20138 | Italy |
| Azienda Ospedaliera Universitaria Pisana | Pisa | Tuscany | 56126 | Italy |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII | Bergamo | 24127 | Italy |
| Ospedale San Raffaele | Milan | 20132 | Italy |
| Hospital Clinico de Valencia | Valencia | Valenciana, Comunitat | 46010 | Spain |
| Hospital Universitario Doctor Peset | Valencia | Valenciana, Comunitat | 46017 | Spain |
| Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE) | Seville | 41003 | Spain |
| Addenbrooke's Hospital | Cambridge | Cambridgeshire | CB2 2QQ | United Kingdom |
| FutureMeds Teesside - Middlefield Centre | Stockton-on-Tees | Durham County | TS19 8PE | United Kingdom |
| Royal London Hospital | London | England | E1 1BB | United Kingdom |
| Futuremeds-Newcastle | Newcastle | England | United Kingdom |
| Vascular Research Team | Salford | Greater Manchester | M6 8HD | United Kingdom |
| North Middlesex Hospital | London | London, City of | N18 1QX | United Kingdom |
| City Hospital, Nottingham University Hospitals NHS Trust | Nottingham | NG5 1PB | United Kingdom |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000729679 | retatrutide |
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